Surgical procedures have been developed for performing gynecologic pelvic surgery by using an operating laparoscope which is inserted into a trocar tube or sleeve extending through an incision in the body into the pelvic area. The operating laparoscope includes a separate optical passage for viewing the surgical area and an operating channel for the passage of instruments or a laser beam to perform surgery on the tissue inside the body. Also, most surgical procedures require the use of ancillary trocar tubes for passage of additional surgical instruments. Typically, a trocar is inserted into the trocar sleeve to facilitate the insertion of the trocar sleeve through an incision and its penetration through the body wall. After the trocar sleeve is positioned at a desired surgical site, the trocar is removed from the trocar sleeve to allow the operating laparoscope to be inserted into the trocar sleeve and advanced into position to view the surgical site. Then, the additional ancillary trocar ports are created, as necessary, to support the surgical procedure. The desired surgery is performed by inserting an operating instrument, e.g., grasping forceps or scissors, into the appropriate trocar port.
After the surgical procedure is performed, an adhesion barrier is applied to the surgical site to reduce the adhesion formation at the site. The adhesion barrier is applied to the traumatized tissue surfaces after hemostasis to physically separate opposing tissue surfaces during the period of repair or reperitonealization of the tissue. The adhesion barrier consists of material which is absorbable by the body tissue at the site of implantation. For example, an adhesion barrier known as INTERCEED.TM. (TC-7) Absorbable Adhesion Barrier has been developed by Johnson & Johnson which consists of an absorbable knitted fabric composed of oxidized regenerated cellulose.
In the prior art procedure, the installation of the adhesion barrier is performed by using a grasping forceps which is inserted into the channel in the operating laparoscope. Before the insertion of the grasping forceps, the operating laparoscope is removed from the trocar sleeve and cleaned if blood or fluid is present. The grasping forceps is inserted into the operating channel and used to grasp one corner of the adhesion barrier beyond the distal end of the laparoscope. Then, the forceps is drawn backward to pull the adhesion barrier into the operating channel until the adhesion barrier is enclosed within the distal end of the laparoscope. Next, the laparoscope is again inserted into the body via the trocar sleeve and positioned over the desired application area. The grasping forceps is pushed into the operating laparoscope to push the adhesion barrier into the body cavity. Thereafter, by using additional grasping instruments inserted into the body through separate trocar sleeves or tubes, the surgeon can manipulate the adhesion barrier into the desired placement over the traumatized tissue, .e.g., a peritoneal defect. After placement on the tissue, the adhesion barrier is moistened with irrigation fluid, e.g., a saline solution.
The installation procedure of the prior art requires the surgeon to perform a complicated series of steps including the removal and cleaning of the laparoscope, the insertion of the grasping forceps into the operating channel to grasp the adhesion barrier at the distal end of the laparoscope, the retraction of the forceps and the adhesion barrier into the laparoscope, the reinsertion of the laparoscope into the trocar sleeve, and the manipulation of the adhesion barrier at the surgical site by using additional grasping instruments inserted into the body through additional trocar sleeves or tubes. These steps are time consuming and the required manipulation of the adhesion barrier is difficult to perform due to the limited space inside the body.
In the prior art, it is known to utilize an inserter device for the purpose of installing an absorbant tampon in the internal vaginal cavity. For example, U.S. Pat. No. 3,857,395 discloses an inserter device which includes a pair of outwardly bendable arms which bilaterally spread the tampon within the vaginal cavity. However, the disclosed inserter device is not suitable for insertion into a laparoscope for applying an adhesion barrier through a trocar sleeve or tube to an application area where surgery has been performed.
In addition, other types of instruments are known in the prior art for manipulating internal body tissue. For example, U.S. Pat. No. 4,909,789 discloses observation assisting forceps including a set of expandable wires mounted on a shaft which is normally retracted into a sheath. When the shaft is advanced, the wires project out of the sheath and expand into a fan-shaped configuration in the same plane. The expanded wires can be used to set aside internal organs obstructing the observation with an abdominal cavity endoscope. The wires are provided at the tips with spherical members which prevent the organs from being hurt.
U.S. Pat. No. 4,654,028 discloses an incision opening expansion holder including a plurality of wires at the end of an inner tube which are three dimensionally expanded when projecting out of an outer tube to expand an incision of a blood vessel graft for purposes of inosculation. U.S. Pat. No. 4,705,041 discloses a tissue dilator comprising a catheter which supports an expandable member, e.g., a balloon or a scissor-like member. U.S. Pat. No. 1,878,671 discloses a dilator for opening a body cavity including an ovate head mounted on a wire received in a tube which is inserted into the body cavity. U.S. Pat. No. 4,655,219 discloses a tissue grasping accessory including a plurality of flexible grasping arms for use with an endoscopic instrument to grasp a tissue specimen. U.S. Pat. No. 4,590,938 discloses a device for removal of kidney stones through the working channel of an endoscope including a basket comprising four outwardly bowed, generally flat spring arms which are expandable into a bulbous shape and collapsed when retracted into a sheath. The relatively broad, flat surfaces of the spring strips deflect the kidney tissue surrounding the stone while the distally enlarged volume of the basket allows the surgeon to dislodge and capture the stone.
None of the above described devices are particularly suited for use in applying and spreading a sheet of surgical material, e.g., an adhesion barrier, through an endoscopic tube to traumatized tissue after surgery. Moreover, it appears that several of the devices may have a tendency to damage the tissue if attempted to be used to install an adhesion barrier over internal body tissue.
Accordingly, it is an object of the present invention to provide an applicator which is adapted to simplify the application of a sheet of surgical material such as an adhesion barrier to internal body tissue.
Another object of the invention is to provide an applicator to facilitate the installation of a sheet of surgical material such as an adhesion barrier through an endoscopic tube to tissue in a body cavity.
It is also an object of the invention to provide an adhesion barrier applicator which is suitable for insertion through an endoscopic tube and is adapted to spread the adhesion barrier over the tissue application area to minimize the need for manipulation of the adhesion barrier by separate grasping instruments.